Intermediate Risk Prostate CancerPRO-EPINCT03340272
PROspective Multicenter Observational Study on Elective Pelvic Nodes Irradiation.
An observational study of Intermediate Risk Prostate Cancer and High Risk Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intermediate Risk Prostate Cancer, High Risk Prostate Cancer
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 21 Feb 2017to 21 Feb 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for prostate cancer without or after surgery, with or without association of hormonal treatment.
Who may be able to join
- Men older than or aged 18 years;
- Histologically confirmed intermediate, high or very high risk prostate cancer patients (NCCN classification: Intermediate Risk T2b and T2c or Gleason Score 7 or Prostate specific antigen (PsA) value between 10 and 20 ng/mL; High risk: T3a or Gleason score 8-10 or PSA > 20 ng/ml; Very high risk: T3b-T4 or patients with multiple adverse risk factors reported in the high risk category that may be shifted in the very high risk group
- Patients eligible for -and actually submitted to- radical radiotherapy treatment (+/- androgen deprivation) or adjuvant radiotherapy treatment after surgery (radical prostatectomy +/- pelvic lymphadenectomy);
- No other synchronous or previous malignant tumor other than skin basal cell carcinoma;
- Patients able to understand and sign the appropriate informed consent;
- Patients able to fill the QoL questionnaire;
Who cannot join
- Patients aged less than 18;
- Patients not eligible for -and actually not submitted to- radical radiotherapy treatment (+/- androgen deprivation) or adjuvant radiotherapy treatment after surgery (radical prostatectomy +/- pelvic lymphadenectomy);
- Low risk prostate cancer (<T2b and T2c or < Gleason Score 7 or PSA value < 10 ng/mL);
- Patients with synchronous or previous malignancy other than skin basal cell carcinoma;
- Patients able to understand and sign the appropriate informed consent (IC) who decide not to subscribe IC;
- Patients not able to understand and sign the appropriate informed consent (IC)
- Patients unable to fill the QoL questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROspective Multicenter Observational Study on Elective Pelvic Nodes (PRO-EPI) Irradiation in Patients With Intermediate/High/Very High Risk Prostate Cancer
The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT).
The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.
Read the detailed description
Clinical features and outcomes of the patients included in the study will be assessed as better detailed in the following lines:
- To define the diffusion of the practice of treating pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer (PCa) among Italian Radiation Oncology Centers, submitted to radical or post-operative radiotherapy;
- To define the diffusion of the different radiotherapy techniques used to treat pelvic nodes and the other features of the radiation treatment;
- To register prospectively biochemical and clinical failure, prostate cancer deaths and deaths for any cause in the population studied;
- To register prospectively the toxicity due to radiotherapy and androgen deprivation therapy in patients treated with pelvic nodes radiotherapy;
- To compare clinical outcomes and toxicities observed in the different clinical and therapeutic subgroups with the corresponding historical data relative to PCa patients treated with radiotherapy with or without elective pelvic nodal irradiation, already available in the existing Italian Society of Radiation Oncology databases;
- To exploit the collected data to define the need and the features of a prospective randomized trial evaluating the efficacy of elective pelvic nodal irradiation in patients with intermediate/high/very high risk non-metastatic prostate cancer.
- Keywords
- prostate cancer, pelvic irradiation, hormonal treatment
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Practice of pelvic irradiation
Evaluate the number of patients treated with RT on pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer
Measured: Four months after the end of the enrollment
Secondary outcomes (7)
Radiotherapy techniques used for prostate cancer irradiation
Analyze the number of patients treated with 3Dconformal Radiotherapy (3DCRT), Intensity Modulated Radiation Therapy (IMRT), Volumetric arch Therapy (VMAT), Tomotherapy, respectively with/without Image Guided Radiotherapy (IGRT) for pelvic irradiation
Measured: Four months after the end of the enrollment
Outcome of treated prostate cancer
Biochemical relapse free survival
Measured: Three years after the end of the enrollment
Outcome of treated prostate cancer
Clinical relapse free survival
Measured: Three years after the end of the enrollment
Outcome of treated prostate cancer
Disease specific free survival
Measured: Three years after the end of the enrollment
Outcome of treated prostate cancer
Overall survival
Measured: Three years after the end of the enrollment
Toxicity of treated prostate cancer
register, using CTCAE v.4 acute and late urinary and rectal toxicities in the groups of patients treated with/without pelvic irradiation.
Measured: Within 6 months after the end of the treatment
Comparison of toxicity and outcome in the different groups
Using chi-square test compare toxicities and clinical outcome in the different groups of patients.
Measured: Three years after the end of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start21 Feb 2017
- Primary completion21 Feb 2020
- Study completion21 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Risk Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Michela Buglione, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Michela Buglione, Prof, Principal investigator, University and Spedali Civili - Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340272
- Sponsor's protocol ID
- NP2283
- Acronym
- PRO-EPI
- Status last verified
- Mar 2020
- First submitted
- 30 Oct 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Multicenter Observational Study on Elective Pelvic Nodes (PRO-EPI) Irradiation in Patients With Intermediate/High/Very High Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT03340272
- Acronym / sponsor ID
- PRO-EPI / NP2283
- Keywords
- prostate cancer, pelvic irradiation, hormonal treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2023 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT).
The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.
Detailed description
Clinical features and outcomes of the patients included in the study will be assessed as better detailed in the following lines:
- To define the diffusion of the practice of treating pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer (PCa) among Italian Radiation Oncology Centers, submitted to radical or post-operative radiotherapy;
- To define the diffusion of the different radiotherapy techniques used to treat pelvic nodes and the other features of the radiation treatment;
- To register prospectively biochemical and clinical failure, prostate cancer deaths and deaths for any cause in the population studied;
- To register prospectively the toxicity due to radiotherapy and androgen deprivation therapy in patients treated with pelvic nodes radiotherapy;
- To compare clinical outcomes and toxicities observed in the different clinical and therapeutic subgroups with the corresponding historical data relative to PCa patients treated with radiotherapy with or without elective pelvic nodal irradiation, already available in the existing Italian Society of Radiation Oncology databases;
- To exploit the collected data to define the need and the features of a prospective randomized trial evaluating the efficacy of elective pelvic nodal irradiation in patients with intermediate/high/very high risk non-metastatic prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for prostate cancer without or after surgery, with or without association of hormonal treatment.
Key inclusion criteria (6 listed)
- Men older than or aged 18 years;
- Histologically confirmed intermediate, high or very high risk prostate cancer patients (NCCN classification: Intermediate Risk T2b and T2c or Gleason Score 7 or Prostate specific antigen (PsA) value between 10 and 20 ng/mL; High risk: T3a or Gleason score 8-10 or PSA > 20 ng/ml; Very high risk: T3b-T4 or patients with multiple adverse risk factors reported in the high risk category that may be shifted in the very high risk group
- Patients eligible for -and actually submitted to- radical radiotherapy treatment (+/- androgen deprivation) or adjuvant radiotherapy treatment after surgery (radical prostatectomy +/- pelvic lymphadenectomy);
- No other synchronous or previous malignant tumor other than skin basal cell carcinoma;
- Patients able to understand and sign the appropriate informed consent;
Key exclusion criteria (7 listed)
- Patients aged less than 18;
- Patients not eligible for -and actually not submitted to- radical radiotherapy treatment (+/- androgen deprivation) or adjuvant radiotherapy treatment after surgery (radical prostatectomy +/- pelvic lymphadenectomy);
- Low risk prostate cancer (<T2b and T2c or < Gleason Score 7 or PSA value < 10 ng/mL);
- Patients with synchronous or previous malignancy other than skin basal cell carcinoma;
- Patients able to understand and sign the appropriate informed consent (IC) who decide not to subscribe IC;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Practice of pelvic irradiation
Time frame: Four months after the end of the enrollment
Evaluate the number of patients treated with RT on pelvic lymph-nodes in patients affected by intermediate/high/very high risk non-metastatic prostate cancer
7 secondary outcomes
Radiotherapy techniques used for prostate cancer irradiation
Time frame: Four months after the end of the enrollment
Outcome of treated prostate cancer
Time frame: Three years after the end of the enrollment
Outcome of treated prostate cancer
Time frame: Three years after the end of the enrollment
Outcome of treated prostate cancer
Time frame: Three years after the end of the enrollment
Outcome of treated prostate cancer
Time frame: Three years after the end of the enrollment
Toxicity of treated prostate cancer
Time frame: Within 6 months after the end of the treatment
Comparison of toxicity and outcome in the different groups
Time frame: Three years after the end of the enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michela Buglione, Prof principal investigator
University and Spedali Civili - Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermediate Risk Prostate Cancer and High Risk Prostate Cancer, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Practice of pelvic irradiation (time frame: Four months after the end of the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.